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PROTONIX® IV Index Section (pantoprazole sodium for injection)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis

1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

2.2 Preparation and Administration Instructions for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

2.3 Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

2.4 Preparation and Administration Instructions for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

2.5 Compatibility Information

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

5.2 Hypersensitivity and Severe Skin Reactions

5.3 Injection Site Reactions

5.4 Potential for Exacerbation of Zinc Deficiency

5.5 Acute Tubulointerstitial Nephritis

5.6 Clostridium difficile-Associated Diarrhea

5.7 Bone Fracture

5.8 Cutaneous and Systemic Lupus Erythematosus

5.9 Hepatic Effects

5.10 Hypomagnesemia

5.11 Fundic Gland Polyps

5.12 Interference with Investigations for Neuroendocrine Tumors

5.13 Interference with Urine Screen for THC

5.14 Concomitant Use of PROTONIX I.V. with Methotrexate

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.5 Pharmacogenomics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Gastroesophageal Reflux Disease (GERD) Associated with a History of Erosive Esophagitis

14.2 Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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